A Long-Term Prospective Randomized Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients – The REMADHE Study - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00505050

Purpose

Recent meta-analysis reported reduction in mortality and hospitalization of HF patients.However, important issues in DMP for HF remain to be resolved. DMP are not homogeneous concerning methodology and in general included only elderly patients; most were tested in high-risk HF patients discharged from hospital; quality of life results are controversial; few reports included long-term results; some protocols had limited enrollment of screened patients, and it was suggested that could be less effective when patients are already followed by HF specialist.Improved survival was associated with cardiologist care as well with multidisciplinary teams providing specialized follow-up.Whether both together could benefits HF is not well defined. Also, no studies reported the long-term effects of a cyclic repetitive reeducation program.We tested whether a DMP that consisted of a long-term repetitive education program associated with a telephone monitoring could benefit HF outpatients in usual ambulatory care already under care of cardiologist with experience in HF

Condition	Intervention	Phase
Heart Failure	Other: Disease Program Management	Phase III

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

The prespecified primary end-points were (1) combined death secondary to any cause or unplanned first hospitalization and (2) quality of life changes.

Secondary Outcome Measures:

(1) DMP feasibility;(2) death;(3)number and duration of hospitalization; (4) unexpected death in home and death during hospitalization; (5)emergency care necessity,(5) adherence.

Study Start Date:	October 1999
Study Completion Date:	September 2006

Arms	Assigned Interventions
1: No Intervention Standard follow-up medical visits and treatment for control group were performed during the study period by the same cardiologist team that was not informed of the randomization.	Other: Disease Program Management This DMP inclused intervention content with education for out patients and caregivers; medication management with optimized therapy based on guidelines, and remote monitoring; delivery personnel with nurses, cardiologists, pharmacists, social workers, dietitians, physical therapists, psychologists; face-to-face individual/group communication, and telephone in-person; the intensity/complexity was long-term follow-up with 6 months interval repetitive education; the environment was hospital out-patient; and the outcomes measured were clinical, quality of life, and adherence. After randomization patients undergone our multidisciplinary education sessions 60-minute long that covered the basic principles related to heart failure. Telephone calls were used to reinforce the contents of the sessions of the ambulatory education activity, and monitoring of the compliance/adherence, symptoms/signs of worsening heart failure, and self-control mechanisms.

Arms

Assigned Interventions

1: No Intervention

Standard follow-up medical visits and treatment for control group were performed during the study period by the same cardiologist team that was not informed of the randomization.

Other: Disease Program Management

This DMP inclused intervention content with education for out patients and caregivers; medication management with optimized therapy based on guidelines, and remote monitoring; delivery personnel with nurses, cardiologists, pharmacists, social workers, dietitians, physical therapists, psychologists; face-to-face individual/group communication, and telephone in-person; the intensity/complexity was long-term follow-up with 6 months interval repetitive education; the environment was hospital out-patient; and the outcomes measured were clinical, quality of life, and adherence.

After randomization patients undergone our multidisciplinary education sessions 60-minute long that covered the basic principles related to heart failure. Telephone calls were used to reinforce the contents of the sessions of the ambulatory education activity, and monitoring of the compliance/adherence, symptoms/signs of worsening heart failure, and self-control mechanisms.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible patients on ambulatory care were aged 18 years or older with irreversible chronic heart .failure with at least 6 months duration, and non planned surgical procedure or other procedure that could influence the follow-up in the next 6 months

Exclusion Criteria:

impossibility for attendance of education sessions and monitoring based on non corrected limitations of transport, or unfavorable distance, or social, or of communication; myocardial infarction or unstable angina within 6 months before randomization; cardiac surgery or angioplasty within 6 months randomization; hospitalized patients or recent discharged patients; severe renal/hepatic/neurological/pulmonary or any systemic disease that could confuse the interpretation of results and impair expected survival; and pregnant women or women of childbearing potential.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505050

Locations

Brazil, SP
Heart Institute of São Paulo University Medical School
Sao Paulo, SP, Brazil, 05403-000

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

Edimar Bocchi

Heart Institute of São University Medical School

More Information

Study ID Numbers:	829/99
Study First Received:	July 18, 2007
Last Updated:	July 18, 2007
ClinicalTrials.gov Identifier:	NCT00505050
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

heart failure, disease program management, treatment, education

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009